# K972258: HI-Care Closed Suction System

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Dec 29, 1997 after 195 days
- Product code: BSY (Catheters, Suction, Tracheobronchial)
- Device class: 1
- Regulation: 21 CFR 868.6810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031997: Mallinckrodt Dar TY-Care / TY-Care Exel Closed  Suction System (2003), 0 descendants of its own

## Indications for use
This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions. This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.

Source page: https://510kreport.com/device/K972258
Methodology: https://510kreport.com/methodology